Home Applications 209575 Application 209575
Type NDA
Sponsor CODY LABS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NUMBRINO COCAINE HYDROCHLORIDE SOLUTION;NASAL 4% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209575-001 NUMBRINO COCAINE HYDROCHLORIDE 4% SOLUTION / NASAL RLD, RS 2020-01-10
Orange Book patents# Current patent rows page 1 of 1 · 18 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209575-001 NUMBRINO 4% SOLUTION / NASAL 2020-01-10 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N209575-001 NUMBRINO 4% SOLUTION / NASAL RLD, RS 2020-01-10 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 10 · 396 observed states.
Observed Orange Book exclusivity history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0527-1961 NUMBRINO cocaine hydrochloride nasal Lannett Company, Inc. NDA Current 0527-1961 NUMBRINO cocaine hydrochloride nasal Lannett Company, Inc. NDA Current 0527-1961 NUMBRINO cocaine hydrochloride nasal Lannett Company, Inc. NDA Current 0527-1961 NUMBRINO cocaine hydrochloride nasal Lannett Company, Inc. NDA Current 0527-1961 NUMBRINO cocaine hydrochloride nasal Lannett Company, Inc. NDA Current 0527-1961 NUMBRINO cocaine hydrochloride nasal Lannett Company, Inc. NDA Current 0527-1961 NUMBRINO cocaine hydrochloride nasal Lannett Company, Inc. NDA Current 0527-1971 cocaine hydrochloride nasal cocaine hydrochloride nasal Lannett Company, Inc. NDA AUTHORIZED GENERIC Current 0527-1971 cocaine hydrochloride nasal cocaine hydrochloride nasal Lannett Company, Inc. NDA AUTHORIZED GENERIC Current 0527-1971 cocaine hydrochloride nasal cocaine hydrochloride nasal Lannett Company, Inc. NDA AUTHORIZED GENERIC Current 0527-1971 cocaine hydrochloride nasal cocaine hydrochloride nasal Lannett Company, Inc. NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 64440 SUPPL 2020-08-28 63372 ORIG 2020-06-01 61573 ORIG 2020-01-14 61564 ORIG 2020-01-14